Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABI-H3733 Liquid Oral Dosage Form
ABI-H3733 Liquid Dosage Form · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form | EXPERIMENTAL | A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: SAD Cohorts 1-7 Placebo Liquid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form | EXPERIMENTAL | Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 1: MAD Cohorts 8-10 Placebo Liquid Form | PLACEBO_COMPARATOR | Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a ≤3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts. |
| Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form | EXPERIMENTAL | A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form | EXPERIMENTAL | A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Part 2: Single Dose Fed Cohort 12 Placebo Solid Form | PLACEBO_COMPARATOR | A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1. |
| Name | Type | Description |
|---|---|---|
| ABI-H3733 Liquid Oral Dosage Form | DRUG | ABI-H3733 liquid oral dosage form |
| ABI-H3733 Solid Oral Dosage Form | DRUG | ABI-H3733 solid oral dosage form |
| Placebo to ABI-H3733 Liquid Oral Dosage Form | DRUG | Placebo to ABI-H3733 liquid oral dosage form |
| Placebo to ABI-H3733 Solid Oral Dosage Form | DRUG | Placebo to ABI-H3733 solid oral dosage form |
Inclusion Criteria: * No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. Exclusion Criteria: * Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C. * History of or current persistent drug or alco...
ABI-H3733 Liquid Dosage Form is an investigational small molecule developed by Assembly Biosciences, Inc. (ticker ASMB) for the treatment of chronic hepatitis B. It is an oral liquid formulation of the compound ABI-H3733 and has been studied in a Phase 1 clinical trial in healthy adult volunteers.
ABI-H3733 Liquid Dosage Form is being developed for the treatment of chronic hepatitis B, a viral infection of the liver. The clinical program has evaluated the formulation in healthy adult volunteers rather than in patients with chronic hepatitis B, so its use in the target indication remains under investigation.
ABI-H3733 Liquid Dosage Form is developed by Assembly Biosciences, Inc., which trades on the Nasdaq under the ticker ASMB. Assembly Biosciences is the sponsor of the clinical program for this liquid oral formulation of ABI-H3733.
ABI-H3733 Liquid Dosage Form is in Phase 1 development. One Phase 1 trial has been completed, and no active trials of this formulation are currently listed. It is an investigational product and has not been approved by the FDA for any indication.
ABI-H3733 Liquid Dosage Form has been studied in one completed Phase 1 trial, NCT04271592, titled A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults. The trial enrolled 120 healthy adult volunteers in New Zealand and was randomized, double-blind, and placebo-controlled.
Yes. ABI-H3733 Liquid Dosage Form and ABI-H3733 Liquid Oral Dosage Form refer to the same investigational product from Assembly Biosciences. The two names describe the same liquid oral formulation of ABI-H3733 being developed for chronic hepatitis B.